Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of lyr-210 for the treatment of chronic rhinosinusitis in adults (enlighten 2)

Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)

Summary: multicenter, phase iii, randomized, blinded, controlled, parallel group.

this is a 24-week, multicenter, phase iii, randomized, blinded, controlled, parallel group with a 24-week treatment period to evaluate the efficacy and safety of lyr-210 compared with sham control for treatment in adults with crs.

Eligibility criteria:
inclusion criteria: * age ≥18 * diagnosed as having crs * bilateral ethmoid disease confirmed on ct * mean 3 cardinal symptom (3cs) score * undergone at least 2 trials of medical treatments in the past * has been informed of the nature of the study and provided written informed consent * agrees to comply with all study requirements * if currently on a waiting list for sinonasal surgery, willing to be removed from the waiting list or have preplanned surgery date cancelled for the duration of the study. \[note: this does not preclude a participant from receiving or being recommended for sinonasal surgery as rescue treatment during the study\]. exclusion criteria: * inability to tolerate topical anesthesia * previous nasal surgery * presence of nasal polyp grade 2 or higher * seasonal allergic rhinitis * perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids * severe asthma * history or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis * obstruction preventing proper placement and retention of lyr-210 as seen on endoscopy * anatomic variation that, in the opinion of the investigator, would adversely impact placement of lyr-210 as seen on ct * known history of hypersensitivity or intolerance to corticosteroids * known history of hypothalamic pituitary adrenal axial dysfunction * previous pituitary or adrenal surgery * dental procedure/implant on maxillary dentition within 4 weeks of the screening visit. * past or present acute or chronic intracranial or orbital complications of crs * history or diagnosis (in either eye) of glaucoma or ocular hypertension * past or present functional vision in only 1 eye * past, present, or planned organ transplant or chemotherapy with immunosuppression * currently positive for covid-19 or residual sinonasal symptoms from a previous covid-19 infection * pregnant or breast feeding. females of child-bearing potential must test negative for pregnancy at the time of screening * evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments * currently participating in an investigational drug or device study * determined by the investigator as not suitable to be enrolled
study of tau imaging with the use of [18f]mk-6240 tracer

Conditions: Alzheimer Disease

Summary: the recent development of a pet tracer,\[18f\]mk-6240(an\[18f\]tau imaging agent,cerveautechnologies)that has high affinity for the human phosphorylated tau deposits in ad brain offers new opportunities to investigate tau pathology. the investigators will evaluate this imaging agent in individuals from families with a known autosomal dominant alzheimer's disease (adad) mutation. this study of tau pet using \[18f\]mk-6240 is performed in conjunction with dian and dian extended registry (dian-exr).


Eligibility criteria:
inclusion criteria: 1. participants have met all eligibility criteria for enrollment into the dominantly inherited alzheimer's network (dian) and dian extended registry (dian exr) study enrollment criteria. 2. male or female participants, at least 18 years of age. 3. cognitively normal, or with mild dementia, as assessed clinically. 4. participant is able and willing to undergo testing (magnetic resonance imaging (mri)or computed tomography (ct), pet, radioactive tracer injection; forthose unable to undergo mri, ct will be used to generate regions-of interest). 5. pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration. - exclusion criteria: 1. has any condition that, in the investigator's opinion, couldincrease risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severechronic back pain might not be able to lie still duringthe scanning procedures). 2. is deemed likely unable to perform the imaging procedures for any reason. 3. has hypersensitivity to \[18f\]mk-6240or any of its excipients. 4. contraindications to pet, pet-ct or mr(e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate. 5. severe claustrophobia. 6. women who are currently pregnant or breast-feeding, and women who do not agree to use reliable contraception, or to refrain from sexual activity for 24 hours following administration of the \[18f\]mk-6240injection will be excluded from the study. 7. currently participating in any research studyreceiving an active study medication for ad, an investigational drug, device, imaging, or placebo within the past 30 days before screening, and throughout this clinical trial up to 2-weeks past any study-related procedures. 8. other than the dian study, current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the us code of federal regulations (cfr) title 21 section 631.1. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=361.1. it is the responsibility of each site to confirm the date of the most recent pet scan and to work within the guidelines of the local radioactive drug research committee (rdrc) regarding the imaging interval. -

Keywords: tau pet mk 6240 adad
real world study of a adalimumab biosimilar (geleli) in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this multicenter, prospective, observational study is to assess the efficacy and safety of an adalimumab biosimilar (geleli) in rheumatoid arthritis in the real world setting.


Eligibility criteria:
inclusion criteria: * participants who fulfilled the 1987 revised american college of rheumatology (acr) or 2010 acr/eular classification criteria for ra. * participants for whom the rheumatologists have decided to initiate geleli treatment. * participants who provide a written informed consent form of participating in this study. exclusion criteria: * current active or chronic infections, or previous history of active tb infection. * history of malignancy. * congestive heart failure with nyha class iii or iv. * females of childbearing or breastfeeding. * participate in other clinical trial within 3 months. * allergic to the drugs involved in the study. * the investigator believes that the patient is not suitable to participate in this study.
trenev trio®/healthy trinity® for recurrent gastrointestinal symptoms

Conditions: Recurrent Gastrointestinal Symptoms

Summary: clinical trial to compare safety and effectiveness of 10-week supplementation with trenev trio®/healthy trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms.

this study is a double-blind, randomized, placebo-controlled, parallel group trial comparing the safety and effectiveness of supplementation with trenev trio®/healthy trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms. subjects will be recruited and, following successful completion of a 2-week run-in period, will be randomized to trenev trio®/healthy trinity® or placebo and will consume their assigned study product daily for 10 weeks. the study endpoints of this trial include relief of overall gastrointestinal symptoms, acid indigestion, abdominal cramping, constipation, diarrhea, gas, and bloating as well as product safety over the 10-week supplementation period.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. body mass index between 18.5 through 39.9 kg/m2 3. at least three symptoms rated between 4 to 6 in severity (moderate to severe discomfort) on a 1 to 7 scale, one of which must be acid indigestion as determined by the "reflux syndrome" score 4. self-reported "acid indigestion" symptoms (including pain/discomfort beneath the breastbone, bitter fluid in the mouth, or bloating/nausea after eating) at least 3 times per week over the previous 4 weeks 5. agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only) 6. able to understand and voluntarily consent to the study and understand it's nature and purpose including potential risks, and side effects exclusion criteria: 1. any gsrs symptom rated a 7 in severity (very severe discomfort) on a 1 to 7 scale 2. diagnosed gastrointestinal disease/complication or functional bowel disorder (e.g. ibs, functional constipation, ibd, ulcer, etc.) based on physical examination or documented medical history that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints 3. any non-gastrointestinal disease/complication that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints 4. regular (\>3 days per week) prescription medication use for any gastrointestinal disease/condition 5. recent (\<6 months) abdominal surgery for any reason 6. immunodeficiency 7. recent change in anti-psychotic medication within the previous 3 months 8. systemic steroid use within the prior month, excluding regular use of asthma medication 9. pregnant female or breastfeeding 10. eating disorder 11. recent (within 2 weeks) antibiotic administration 12. history of alcohol, drug, or medication abuse 13. daily consumption of probiotics, fermented milk, and/or yogurt 14. known allergies to any substance in the study product 15. participation in another study with any investigational product within 30 days of screening
evaluation of the gore tag thoracic endoprosthesis in the treatment of aneurysms

Conditions: Aortic Aneurysm, Thoracic

Summary: the purpose of this post-approval study is to evaluate the long-term performance of the gore tag® thoracic endoprosthesis (tag device) in the primary treatment of descending thoracic aortic (dta) aneurysms


Eligibility criteria:
inclusion criteria: 1. descending thoracic aortic aneurysm deemed to warrant surgical repair: 1. fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta 2. saccular aneurysm 2. anatomy meets gore tag thoracic endoprosthesis specification criteria as indicated in the instructions for use (appendix a) 3. minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm • \<60 degree angle in the aortic arch may require additional length of non-aneurysmal segment if the arch is included in the treatment segment 4. life expectancy \> 2 years 5. surgical candidate * asa class i, ii, iii, or iv * nyha class i, ii, iii or no heart disease 6. male or infertile female 7. minimum 21 years of age 8. able to comply with protocol requirements 9. signed informed consent form exclusion criteria: 1. 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta 2. significant thrombus at the proximal or distal implantation zones 3. mycotic aneurysm 4. hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture) 5. acute or chronic aortic dissection 6. planned occlusion of the left carotid or celiac arteries 7. "planned" concomitant surgical procedure (other than left subclavian transposition) or previous major surgery within 30 days 8. myocardial infarction or cerebral vascular accident within 6 weeks 9. severe respiratory insufficiency sufficient that precludes open thoracotomy 10. renal insufficiency (creatinine \> 2.0 mg/dl) with or without dialysis 11. degenerative connective tissue disease, e.g., marfan or ehler-danlos syndrome 12. participation in another investigational device or drug study within 1 year 13. documented history of drug abuse within 6 months
efficacy of combined contraceptive vaginal ring(nuvaring)in women with idiopathic menorrhagia

Conditions: Menorrhagia

Summary: to compare the efficacy of a combined contraceptive vaginal ring (nuvaring) and oral norethisterone acetate in treatment of idiopathic heavy menstrual bleeding during fertile age


Eligibility criteria:
inclusion criteria: * women with heavy menstrual bleeding based on pbac score over 185 (mean of two control cycles)and desire contraception exclusion criteria: * menorrhagia of endocrine or systemic origin * other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.

Keywords: menorrhagia vaginal ring norethisterone acetate
normative assessment of adaptable mouthguards.

Conditions: Oral Manifestations

Summary: the aim of this study is to the validate adaptable mouthguards prototypes, patented by bordeaux university and bordeaux university hospital.

the current state of knowledge in the areas of mouthguards shows that type ii (adaptable) models account for 90% of the mouthguards of the sporting population. but a majority of these devices do not appear to comply with the european directive 89/686 / european economic community. a previous work consisted of the production of prototypes of mouthguards meeting the essential requirements of the directive. these prototypes were the subject of a patent filed by the bordeaux university and the bordeaux university hospital. the aim of this study is to the validate the prototypes for a future launch on the market.

Eligibility criteria:
inclusion criteria: * subject aged 18 to 35, * subject affiliated to a social security, * subject who has signed the free and informed consent form. exclusion criteria: * subject with a pathology incompatible with the performance of the test, namely: recent infarction,threat syndrome, blood pressure resting\> 200/120 mmhg, uncompensated cardiac insufficiency, atrioventricular block 3rd degree acquired, myocarditis, pericarditis, endocarditis, aortic dissection, intracardiac tumor or thrombus, deep vein thrombosis, pulmonary embolism, * subject under b-mimetic drug treatment, * subject under safeguard of justice, * subject participating in another search, * subject during pregnancy.

Keywords: prototype adaptable mouthguards
effectiveness of cortiment® in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate cortiment® with regard to its use by clinicians in routine clinical practice and its effectiveness and tolerability in a real-life setting.


Eligibility criteria:
inclusion criteria: * men and women aged ≥ 18 years * outpatients * patients who have been prescribed cortiment® for the treatment of mild to moderate active ulcerative colitis within a 5 days' time window prior to being included in the study * patients who have received adequate information regarding this non-interventional study and are able to understand and voluntarily sign the informed consent exclusion criteria: * patients with severe active / fulminant ulcerative colitis * patients treated with antibiotics or corticosteroids for the current flare. use of antibiotics for other conditions non-related to the gastrointestinal tract, either before enrolment or during the observational period is permitted. * history of total / sub-total colectomy * hypersensitivity to the active substance, lecithin (derived soya oil, peanut oil) or to any of the excipients * patients enrolled and involved in an interventional study * patients whom investigators consider inappropriate to participate in the study
analysis of gastrointestinal symptoms of outpatients with functional gastrointestinal diseases（fgids） in grade-a tertiary hospitals in china

Conditions: To Analyze TCM Syndrome and Symptoms of FGIDs Patients

Summary: to analyze the classification characteristics of gastrointestinal symptoms, the quality of life, the degree of anxiety and depression, and the satisfaction with the treatment of chinese medicine in patients with fgids in chinese grade-a tertiary hospitals. the characteristics of tcm（traditional chinese medicine） syndromes and symptoms of the above-mentioned fgids will be analyzed, and the characteristics of tcm syndromes of fgids and their possible relationship with fgids subtypes will be analyzed.


Eligibility criteria:
inclusion criteria: 1. symptoms has appeared for at least 3 months; 2. no organic disease and gastrointestinal alarm symptoms, which meet the diagnostic criteria of fgids; 3. sign informed consent and be able to read and understand the questionnaire. exclusion criteria: 1. a history of organic gastrointestinal diseases; 2. alarm symptoms of digestive tract (such as melena, weight loss, fever, abdominal mass, ascites, anemia, family history of gastrointestinal tumors, etc.) 3. have a history of mental diseases; 4. unable to read and understand the questionnaire.
registry experience at the washington hospital center, des - taxus liberte versus xience v

Conditions: Coronary Artery Disease

Summary: multicenter, retrospective registry to collect 9-12 month follow-up data to evaluate major adverse cardiac events in patients whom have undergone percutaneous coronary intervention and received either taxus liberte or xience v.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older, both genders * underwent pci with taxus liberte (alone) or xience (alone) exclusion criteria: * underwent pci with a non-taxus liberte or xience v des during the same procedure * received both taxus-liberte and xience-v during the same index procedure * patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus clopidogrel or prasugrel).
crp/albumin ratio as a predictive inflammatory marker for postoperative sirs and/or sepsis

Conditions: Crp

Summary: the goal of this observational study is to determine the value of crp/albumin ratio as an inflammatory marker for predicting the development of postoperative systemic inflammatory response syndrome and/or sepsis in polytraumatized patients admitted to intensive care unit. the main question it aims to answer is whether crp/albumin ratio can be used as predictive inflammatory marker for postoperative systemic inflammatory response syndrome and/or sepsis or not.

the development of postoperative systemic inflammatory response syndrome (sirs) or sepsis is a very serious complication that has been associated with high morbidity, mortality, and increased length of inpatient stay. sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. as surgical interventions lead to well-understood metabolic, neuroendocrine, and immune responses, the stress responses to surgery contribute to increased postoperative complications mostly caused by increased levels of pro-inflammatory cytokines in response to surgical injury, which leads to changes of circulating acute phase proteins, such as albumin and c-reactive protein (crp). the crp to albumin ratio (car) is a new index calculated by dividing crp by the albumin level. it has been assumed to have predictive value in determining morbidity and mortality in many critical diseases.

Eligibility criteria:
inclusion criteria: * patients classified by american society of anesthesiologists physical status (asa) as i to iii. * both sex. * aged ≥ 18 years old. * polytraumatized patients (fulfilling the 'new berlin definition' of polytrauma patient which includes abbreviated injury scale (ais) ≥3 for two or more different body regions with one or more of the following five physiological variables: disturbed level of consciousness, hypotension, coagulopathy, acidosis and age \>70y). * admitted to intensive care unit preoperatively or postoperatively. • surgical intervention within 48 hours of the onset of trauma. exclusion criteria: * patients who used immunosuppressive therapy and chemotherapy. * patients with known hematological disorders or malignancy. * patients with known liver cirrhosis classified as child- pugh c ( serum albumin \ 2.2 ) (tsoris , et al.,2023) or liver cell failure. * patients receiving albumin supplementation during the period of the study. * age \< 18y.

Keywords: crp/albumin ratio systemic inflammatory response syndrome sepsis postoperative
safety and pharmacokinetics of zanubrutinib (bgb-3111) in healthy subjects and those with impaired liver function

Conditions: Hepatic Insufficiency & Healthy Subjects

Summary: this study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects


Eligibility criteria:
inclusion criteria: * male and/or female subjects in good health as determined by past medical history, physical examination, vital signs, ecg and laboratory tests at screening. * subjects must have a body mass index (bmi) between 18 and 40 kg/m2 to participate at screening. * female subject must be of non-childbearing potential, i.e. surgically sterile at least 6 months prior to screening with supportive clinical documentation or post-menopausal must have no regular menstrual bleeding for at least 12 months prior to inclusion. menopause will be confirmed by a plasma fsh level of \>40 iu/l * male subjects must agree to practice 2 highly effective methods of birth control at least one method must be barrier technique. additional inclusion criteria for healthy subjects only: * in good health as determined by past medical history, physical examination, vital signs, ecg, and laboratory tests at screening; subjects without diseases/conditions * matched with a hepatic impaired patient (mild, moderate or severe, as applicable) using the following criteria: sex, age ±10 years and body mass index (bmi)± 10 kilograms additional inclusion criteria for hepatic impaired subjects only: * history of cirrhosis with supportive documentation (ultrasonography, computed tomography scan, liver biopsy, magnetic resonance imaging, clinical laboratory tests results or physical signs consistent with a clinical diagnosis of liver cirrhosis. * child-pugh clinical assessment score consistent with degree of hepatic impairment. * blood pressure of 90 to 155 mmhg (systolic) and 50 to 100 mmhg (diastolic). * otherwise considered healthy in general as determined by physical examination findings and laboratory assessments within normal limits. exclusion criteria: * subjects with a clinically relevant history or presence of any clinically significant disease. * history of drug or alcohol abuse within the 12 months prior to dosing. * a positive human immunodeficiency virus (hiv) type 1 or 2 test result at screening. * history of blood donation of 500 ml or more of blood within 2 months prior to screening * a positive tuberculosis test result. additional exclusion criteria for hepatic impaired subjects only: * received a liver transplant * acute or exacerbating hepatitis * active stage 3 or 4 hepatic encephalopathy * previously diagnosed with hepatocellular carcinoma, or a history of cholestatic liver disease or biliary sepsis within the past 2 years. * additional exclusion criteria for healthy subjects only: a positive hepatitis b surface antigen (hbsag) or hepatitis c test result. * history of any clinically significant chronic and/or active hepatic disease.

Keywords: bgb-3111 zanubrutinib pharmacokinetics healthy subjects hepatic impairment